Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,079
- 试验地点
- 1
- 主要终点
- Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization
研究概览
简要总结
Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.
详细描述
In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.
Primary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.
Secondary objectives:
- To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.
- To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.
- To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.
- To determine predictors of non-adherence to care-seeking for HPV positive women.
- To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.
- To calculate the economic cost of both strategies.
Mixed method design, quantitative and qualitative informations will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30-49 years
- •Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).
- •Non-inclusion criteria:
- •Pregnancy at the time of screening
- •History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).
- •Intra-vaginal treatment
排除标准
- •Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- •Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- •Women who are not able to comply with the study protocol.
- •Previous hysterectomy
- •Known cervical cancer
结局指标
主要结局
Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization
时间窗: 3 months
The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm
次要结局
- Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm(3 months from sensitization)
- Number and percentage of participants once tested HPVpositive who will link to the pelvic exam for visual assessment and treatment (if needed) within 3 months.(3 months from HPV self sample collection)
- Identify barriers and enablers to the home-HPV self-sampling test.(4 months)
- Identify barriers and enablers of linkage to VIA for HPV positive women(4 months)
- Number of pre-cancers and/or cancers diagnosed in each study arm.(2 years)
- Cost of each screening strategy.(2 years)
研究者
Prof. Patrick Petignat
Professor
University Hospital, Geneva